Quality Management, End-to-End

Capture nonconformances at receiving, production, or CCP checkpoints. Auto-generated NC numbers, photo attachments, severity classification, and escalation to SCAR or CAPA in one click.

Structured supplier corrective action requests with 5-stage progression: issued, supplier response, operations review, effectiveness review, closed. 30-day supplier response SLA tracked automatically.

CAPA records with 6-stage workflow, root cause analysis, corrective action description, responsible party assignment, and effectiveness review sign-off.

Out-of-spec events linked to the originating test result, with disposition workflow and auto-escalation to CAPA when required by your protocol.

Three CoA scenarios: Scenario A generates from batch test results, Scenario B from external lab data, Scenario C from specification only. QA approval gated, PDF delivery to customers, auto-linked to finished product lots.

Metal detector, magnet, and screener verifications with start/end range capture, standards checked (JSON), pass/fail/corrective action result. Abnormal finding automatically creates an NC record and halts the line.

Customer complaints with +5 business day initial review SLA, retain sample review, batch record review, returned product tracking, root cause analysis, and CAPA linkage.

SOPs, Forms, and Programs organized by document type and category. Upload, version-track, and distribute - with SAS-URL secure downloads that expire after 1 hour.

Digital 9-section investigation workflow: five-whys root cause analysis, CAPA actions, effectiveness gate, and closure sign-off - all in a single linked record. Every section timestamped and audit logged.

Management of Change triggers downstream actions - training assignments, SOP revision tasks, profile revision gates, and customer notification requirements. APR auto-populates from 8 live data sources: batches, yield, NCs, OOS, complaints, SCARs, CAPAs, and CoAs.

Cross-join compliance matrix showing every employee against every training program with expiry status. Employee onboarding workflow with 10-item checklist, sequential numbering, and overdue alerts to the dashboard.

Every approval action, lot release, CAPA sign-off, and SOP acknowledgment is backed by an electronic signature captured against the authenticated user identity. 34 dedicated signature endpoints across the platform. Every one timestamped, every one immutable.

Every API endpoint is guarded at the middleware layer by role-based access control. Admins, quality managers, production operators, and read-only users each see only what their role permits. Access control is enforced server-side on every request, not just in the frontend.